CLASS II Drug recall · Reported 9 Jul 2014 · FDA Enforcement Report
Brevibloc Premixed Injection, Esmolol Hydrochloride recalled
Baxter Healthcare is recalling Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/ (10, distributed nationwide in the US. The recall was initiated on 16 Jun 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1413-2014
- FDA event ID
- 68577
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Brevibloc
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2014
- FDA classified
- 1 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Jun 2014 | Recall initiated by company | |
| 1 Jul 2014 | Classified by FDA | +15 days |
| 9 Jul 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Product as listed by the FDA
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Which lots are affected?
Lot #: C926923, Exp 01/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Esmolol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esmolol HCl 100 mg/ (10mg/ mL) Single Dose Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Esmolol HCl Injectable Solution 100 mg recalled by Advanced Pharma | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Esmolol HCl in all strengths, all doses, and all packaging recalled | Pharmedium Services | Sterility | Nationwide |
| Drug | CLASS II | Brevibloc Double Strength Premixed Injection recalledBrevibloc | Baxter Healthcare | Other | Nationwide |